News & Commentary

Kidney Disease Linked to PPI Use

The link between proton pump inhibitors (PPIs) and chronic kidney disease (CKD) might be even closer than previously documented, according to a recent study in the Journal of the American Society of Nephrology.

Researchers at the VA Saint Louis Health Care System found that people without kidney disease who start using PPIs are 30% more likely to develop CKD five years down the line.

What made headlines, though, was that researchers also linked PPIs to CKD progression all the way through to end-stage renal disease (ESRD). Those taking PPIs were 96% more likely to develop ESRD than patients who take H2 blockers. The risk of kidney function decline was 32% higher and the risk of getting kidney disease 28% higher when taking PPIs compared with H2 blockers.

“The results also suggest a graded relationship between duration of exposure and risk of renal outcomes,” the study stated. In other words, the longer you take PPIs, the more the risk, pointing to a systemic failure in monitoring approved medications, the study said.

The study noted that the Sentinel Initiative, launched by the FDA, was created specifically for this problem, namely, to “uncover latent adverse events” of already approved medications. The initiative, however, has not yet comprehensively fulfilled the mandate required by the Food and Drug Administration Amendments Act (FDAAA), which became law in September 2007, the study’s corresponding author, Ziyad Al-Aly, tells Managed Care.

The Sentinel program was formally launched in 2008, but there were some delays in implementation, according to Al-Aly. The initial phase, called MiniSentinel, just concluded, and the full-scale program just started, he says.

The law mandates that the FDA develop an enhanced ability to monitor the safety of drugs after these products reach the market, he says. “The FDA and its partners should do more to leverage the power of big data and advanced analytics to proactively and systematically detect adverse events of approved pharmaceuticals,” Al-Aly says.

The health and cost implications are immense. Millions of Americans are prescribed PPIs and millions more can buy them over the counter.

Researchers in the Journal of the American Society of Nephrology study analyzed information in national VA databases on 20,270 people who had recently started taking PPIs. They also looked at data on 173,321 people who started taking H2 blockers. The data were gathered between Oct. 1, 1999 and Sept. 30, 2006. About this time last year, Managed Care reported that chronic kidney disease threatens to become a major health and cost burden in coming years. More than half (54%) of Americans ages 30 and older who don’t currently have CKD will develop the condition some time in their lives.

The main risk factors for CKD include diabetes, hypertension, and age. Early detection and treatment of CKD can forestall or delay heart disease and kidney failure. Likewise, early treatment of diabetes and hypertension can prevent CKD from developing. Some experts point out that the clinical significance of early stage CKD among the elderly with borderline numbers is somewhat debatable, partly because of competing health problems.

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